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Clinical Trials For New Stents In The Heart

Genesis is a research leader

The best medical technology of the day is quite often not the best of the future. The skilled cardiologists in the cardiac catheterization suites at Genesis Medical Center, Davenport have created a culture of innovation.

Because of this culture, along with a high volume of catheterization procedures being done each year at Genesis, the catheterization team is often selected to participate in clinical trials.

“This is a program willing to push the envelope to find new methods benefitting patients,’’ said cardiologist Eric Dippel, M.D. “You need a desire to do things differently to see if they can be better. That desire comes from an entire team. The physicians, the hospital and Genesis Health System want to be leaders when it comes to innovation, not followers.’’

Participation in clinical trials is not unusual within Genesis Health System. Dozens of trials may be going on at one time for cancer, orthopedic, and heart patients. The trials often allow patients to stay close to home and still receive new advancements in care.

One of the groundbreaking trials going on at Genesis is a nationwide study of dissolvable stents to open heart arteries. No other hospital in Iowa, or in the region, is participating at this time.

Genesis is part of a nationwidestudy of the ABSORB dissolvablestents. The stent is coated with adrug to prevent re-narrowing ofthe artery.

Patients who have an artery that is constricted have increased risk of more serious heart disease. Patients who meet the criteria of the study may be asked to participate in the study of stents that are in the artery only temporarily before dissolving.

Cardiologist Nicolas Shammas, M.D., is the principal investigator at Genesis for the clinical trial of ABSORB, which is called a Bioresorbable Vascular Scaffold (stent) by manufacturer Abbott Laboratories.

“What are the advantages? The hope is that there will be reduced clotting with these stents,’’ Dr. Shammas said. “Second, if there is a need for bypass surgery some day, there will not be a stent there to hinder or prevent doing the bypass.

“Third, there may be less need for the use of blood thinners for long periods of time. Those are the advantages everyone is hoping for with bioresorbable stents.’’

Studying dissolvable stents

The dissolvable stents are inserted with the same procedure as the mesh, wire stents now used in most procedures. The dissolvable stents are also coated with an immunosuppressant drug to prevent re-narrowing of the artery.

The major difference is that the wire stents remain in the vessel. The ABSORB stents disappear within two years, leaving only the drug treatment.

“It’s a blind study so the patients don’t really know what they are getting, but it’s not like they are getting something inferior,’’ Dr. Dippel explained. “They are getting the best standard-of-care for today. The stents carry the same drug that the conventional drug-eluting stents have.

“The difference is the hope of less scarring, returning the artery to a more natural condition without the metal stent, and, the improved ability to do bypass surgery should it be needed later. A metal stent stays in and can complicate a bypass surgery.’’

Dr. Dippel agreed with Dr. Shammas that patients in the Quad Cities are not reluctant to try something different.

“There may be some people who are still skeptical and reluctant to try something different, but others like the thought of getting something new," Dr. Dippel said. "They see the big picture of doing something for future patients by participating in a clinical trial.’’

Another trial closes

Another clinical trial of stents is just closing. Cardiologist Jon Robken, M.D., was the principle investigator at Genesis for the EVOLVE trial to study a stent that carries the drug selectively to the wall of the artery. The drug is absorbed, and the bare stent remains.

Dr. Shammas said he has spent much of his medical career in research and clinical trials.

“Research has been my life’s work in medicine,’’ he said. “It’s exciting to be at a place where we have a great team capable of participating in clinical trials. We’re chosen to participate because of the skill of the people here and the high volume of procedures done here.’’

For information about clinical research at Genesis, go to www.genesishealth.com/research.